Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 18
- 主要终点
- Seroconversion rate for HPV 16 and 18 at M18
研究概览
简要总结
PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis is that the immunologic response to tetravalent vaccine in girls who received immunosuppressive treatment is comparable to the immunologic response in girls that are not immunosuppressed.
详细描述
The human papillomaviruses (HPV) are the cause of the most common sexually transmitted infection. Among oncogenic HPV, HPV 16 and 18 are found in 70% of invasive cancers. Among the non-oncogenic HPV, HPV 6 and 11 are found in 90% of anogenital warts. Two prophylactic vaccines are currently available: Gardasil ® protects against HPV 6, 11, 16 and 18 and Cervarix ® that protects against HPV16 and 18. Gardasil ® is indicated for the prevention of high-grade cervical dysplasia (CIN2-3), cancers of the cervix, high-grade dysplasia of the vulva (VIN2-3) and genital warts.
The choice of Gardasil ® is linked to the theoretical risk of graft rejection with the bivalent vaccine, and the fact that the frequency of anogenital warts related to HPV 6 and 11 is increased in the immunocompromised population.
The immunosuppressed women are more likely to present abnormal cervical smears than general population.
A notice on the age of vaccination against HPV for girls to receive a transplant was made by the High Council of Public Health, recommending that vaccination against HPV could be offered to girls to benefit a transplant before the age of 14 years and according to data from the MA. The High Council of Public Health also renewed its request that studies be conducted specifically on the vaccination of girls and young women, immunocompromised, including those receiving immunosuppressive therapy.
The primary objective is to evaluate the persistence of immunological response to tetravalent HPV vaccine at 18 months after first dose of vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age ≥ 9 years and < 18 years
- •Weight ≥ 25 kg
- •Solid organ transplantation: kidney, liver, heart, lung, intestinal or combined transplant; or systemic lupus erythematosus or other systemic immune disease
- •Transplantation or diagnosis of lupus or diagnosis of systemic immune disease since more than 6 months
- •Immunosuppressant treatment by anti-metabolites or calcineurin inhibitors, with or without associated corticosteroids
- •Minimum required period of 3 months considered as stable after transplantation or without relapse of lupus according to physician evaluation
- •In case of sexual activity (assessed by auto-declaration): onset less than one year before inclusion
- •Written informed consent signed by the investigator and the legal representatives of the patient, and assent by the patient
排除标准
- •Male gender
- •Pregnancy
- •Age < 9 years or ≥ 18 years
- •Previous HPV vaccination
- •Immunosuppressive treatment by anti-TNF (adalimumab, etanercept, infliximab) or monoclonal antibodies (rituximab, anakinra, abatacept) during the last 3 months
- •Active malignancy
- •Active opportunistic infection
- •HIV infection
- •Concurrent clinical trial
研究组 & 干预措施
Girls and young womens receiving immunosuppressive treatment
干预措施: HPV prophylactic vaccine Gardasil (Biological)
结局指标
主要结局
Seroconversion rate for HPV 16 and 18 at M18
时间窗: 18 months after first dose of vacinne (i.e. Inclusion visit)
次要结局
- Geometric means of anti-HPV 6, 11, 16 and 18 antibody titers at M7, M18, and M36, respectively.(Samples collected 7, 18 and 36 months after first dose of vaccine)
- Proportion of patients with a good cell response at M7 and M18(7 and 18 months after first dose of vaccine)
- Proportion of patients with genital warts or cervical lesions (if relevant)(36 months after first dose of vaccine)
- Number, type and time of occurrence of adverse events of any grade during 18 months after first dose of vaccine(Assessed at months 2,6,7 and 18 after first dose of vaccine)